Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow.

The Senior Regulatory Affairs Specialist will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Sports Medicine line of products. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business.

Position Duties and Responsibilities

• Represent Regulatory Affairs on development core teams, providing Regulatory feedback and guidance throughout the product development cycle

• Research, develop, and implement regulatory strategies for new and modified medical devices

• Compiles regulatory submissions, filing amendments and correspondence with US and EU regulatory authorities.

• Act as company representative under minimal supervision, developing and maintaining positive relationships with device reviewers through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, and submission reviews

• Collaborates closely with international regulatory associates to develop international regulatory strategies to ensure the successful registration of devices worldwide. Address and resolve requests for additional information.

• Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes

• Participates in process improvement and corporate initiatives as appropriate

• Support various audits.

• Maintain knowledge of current applicable regulations and guidance documents.

• Maintains the highest levels of professionalism, ethics and compliance at all times.

Qualifications

Qualifications

• Minimum of a Bachelors Degree required; Advanced Degree strongly preferred.

• At least 5+ years of regulated medical device industry professional experience (or related) .

• Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives).

• Proven success in the preparation and completion of US, EU, or international regulatory submissions.

• Experience and understanding of product development process and design controls.

• Experience in orthopedics and orthopedic device regulatory requirements, a plus.

• Demonstrated global perspective, cross-functional collaboration and partnership skills

• Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.)

• Strong problem-solving skills and the ability to provide efficient escalation of issues to the appropriate accountable part.

• Excellent written and oral communication skills

• Ability to balance multiple tasks with attention to detail

• This position is located in Raynham, MA and may require up to 10% travel, domestic and/or international.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The anticipated base pay range for this position is $89,000 to $143,750 based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits